MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Swelling/ Edema (4577)

Event Date 03/30/2022

Event Type  Injury  

Event Description

It was reported to fresenius by a user facility clinic manager (cm) that a patient experienced an allergic reaction to the optiflux f180nre dialyzer.During followup the cm stated that the patient was approximately 1h10 minutes into treatment on a fresenius hemodialysis (hd) machine (with fresenius bloodlines) when their blood pressure increased and they experienced swelling of the face, throat constriction, and labored breathing.The cm indicated that the patient required medical intervention (specifics unknown).The patient was sent to the emergency room where they were evaluated and released.Since this event, the patient utilizes revaclear 300 dialyzers.

Manufacturer Narrative

A temporal relationship exists between hd therapy utilizing the fresenius optiflux 180nr dialyzer, and the serious adverse events of hypertension, facial swelling, throat constriction and labored breathing, which required an unspecified medical intervention as well as evaluation in the er.The definitive cause of the events is unknown; therefore, causality could not be firmly established.However, the patient¿s clinical manager reported the patient had a favorable response to an alternative dialyzer (baxter revaclear), which offered a substitute mode of sterilization.The cm reported the patient underwent hd without a return or worsening of the symptoms.Limited information precluded a more comprehensive investigation.Based on the totality of the information available, the fresenius optiflux 180nr dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events.While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Additional information: d9, g1, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The optiflux dialyzer instruction for use indicates the following: ¿in rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit, may occur during hemodialysis.Hypersensitivity reactions may cause mild to severe signs and symptoms, including itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.Patients with a history of hypersensitivity reactions or patients who have a history of being highly sensitive and allergic to a variety of substances should be carefully monitored during treatment.¿ a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

It was reported to fresenius by a user facility clinic manager (cm) that a patient experienced an allergic reaction to the optiflux f180nre dialyzer.During followup the cm stated that the patient was approximately 1h10 minutes into treatment on a fresenius hemodialysis (hd) machine (with fresenius bloodlines) when their blood pressure increased and they experienced swelling of the face, throat constriction, and labored breathing.The cm indicated that the patient required medical intervention (specifics unknown).The patient was sent to the emergency room where they were evaluated and released.Since this event, the patient utilizes revaclear 300 dialyzers.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14193528
• MDR Text Key: 289980472
• Report Number: 0001713747-2022-00135
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 21PU03015
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 70 KG